DTPA Tck-pars-100

KIT FOR THE PREPARATION OF DIETHYLENE TRIAMINE PENTA ACETATE (Sn) Tc-99m INJECTION
Indication: Glomerular clearance measurement/cerebral angioscintigraphy.
Each vial contains, in vacuum, a lyophilized, sterile and pyrogen free
mixture of:
(DTPA) CaNa3diethylene triamine penta acetate
20.0 mg
Stannous chloride dehydrate
0.50 mg
Ascorbic acid
0.018 mg
After adding a sterile and pyrogen free solution of pertechnetate 99mTc, one
obtains an injectable solution of 99mTc - (Sn)-DTPA with the following
characteristics:
Volume
2 - 5 ml
Max. Activity
300 mCi
Radiochemical purity
> 95.0 %
PH
5-6
Storage
Store the kit
2 - 8 c and protect from light
Store the reconstituted kit
15-25C
Preparation
Injection sterile 99mTc (up to 300 mCi) aseptically into the vial in a
volume of 2-5 ml
Dissolve the lyophilized material by shaking the vial for 10 seconds and

wait for 15 minutes.

Examine the radiochemical purity (RCP).
Labelled preparation is to be used within 6 hrs. Within this period the total
RCP of 99mTc-DTPA should be more than 95.0%.
Quality control of 99mTc-DTPA
Whatman paper chromatography No.1 /Methanol- Acetone (1: 1)
Rf 99mTcO-4 = 0.75-1.0
Whatman paper chromatography No.1 /normal saline
Rf 99mTcO2 = 0.0 - 0.2
Biological distribution of 99mTc-DTPA in rat (n = 3), expressed in % injected
dose per critical organ:
Urine (24 hrs)
> 97.0%
Sterility test
Test for sterility on kits for 99mTc-radiopharmaceuticals are carried out as
described in U.S. pharmacopeia.
Pyrogen test
LAL test and rabbit test on kits for 99mTc-radiopharmaceuticals are carried
out as described in U.S. pharmacopeia.

MDP Tck-pars-200

KIT FOR THE PREPARATION OF MEDRONATE (Sn) 99mTc INJECTION

Indication: Diagnostic and study of primary cancers or metastatic bone lesions
.and other bone diseases such as Paget, osteomylitis, fractures,
Each vial contains, in vacuum, a lyophilized, sterile and pyrogen free mixture of:
MDP (methylene diphosphonic acid)
5.0 mg
Stannous chloride dehydrate
0.80 mg
Ascorbic acid
0.50 mg
After adding a sterile and pyrogen free solution of pertechnetate 99mTc, one obtains an injectable solution of 99mTc -(Sn)-MDP with the following characteristics:
Volume
2 - 5 ml
Max. Activity
300 mCi
Radiochemical purity
> 95.0 %
PH
5.0-6.5
Storage
Store the kit
2 - 8 C
Store the reconstituted kit
15 - 25 C
Preparation
Injection sterile 99mTc (up to 300 mCi) aseptically into the vial in a volume
of 2-5 ml.
Dissolve the lyophilized material by shaking the vial for 10 seconds and
wait for 15 minutes.

Examine the radiochemical purity (RCP).

Labelled preparation is to be used within 6 hrs. Within this period the total
RCP of 99mTc-MDP should be more than 95.0%.
Quality control of 99mTc-MDP
Whatman paper chromatography No.1 /Methanol-Acetone (1: 1)
Rf 99mTcO-4 = 0.75-1.0
Whatman paper chromatography No.1 /Phosphoric Acid 15%
Rf 99mTcO-4 = 0.0 - 0.2
Biological distribution of 99mTc-MDP in rat (n = 3), expressed in % injected
dose per critical organ:
Liver, Kidney
< 5.0%
Bone (one femur)
> 2.0%
Stomach, Intestine
< 1.0%
Sterility test
Test for sterility on kits for 99mTc-radiopharmaceuticals are carried out as
described in U.S. pharmacopeia.
Pyrogen test
LAL test and rabbit test on kits for 99mTc-radiopharmaceuticals are carried
out as described in US. pharmacopeia.

DMSA Tck-pars-500

KIT FOR THE PREPARATION OF DIMERCAPTOSUCCINIC ACID (Sn) 99mTc INJECTION

Indication:exploration of the renal morphology and the functional state of
each kidney by measurement of the renal uptake
Each vial contains, in vacuum, a lyophilized, sterile and pyrogen free mixture of:
DMSA (Dimercaptosuccinic Acid)
1.20 mg
Stannous chloride dihydrate
0.35 mg
Ascorbic acid

0.30 mg
Myo-inositol
50.0 mg
After adding a sterile and pyrogen free solution of pertechnetate 99mTc,
one obtains an injectable solution of 99mTc-(Sn)-DMSA with the following
characteristics:
Volume

up to 6.0 ml
Activity
40.0 mCi
Radiochemical purity
> 90.0 %
PH
2.3-3.5
Storage
Store the kit
2-8 C, protect from light
Store the reconstituted kit
15-25 C
Preparation
Inject sterile 99mTc (up to 40 mCi) aseptically into the vial in a
volume of 2.5 ml
Dissolve the lyophilized material by shaking the vial for 10 seconds

Wait for 15 min at the room temperature

Examine the radiochemical purity (RCP)
Labelled preparation is to be used within 4 hours after labelling. Within
this period the total RCP of 99mTc-DMSA should be more than 90.0%.
Quality control of 99mTc-DMSA
P.Chromatography No.1 (Whatman)/MEK/Glycine 5%
Rf 99mTcO-4=0.8-1.0
Rf 99mTcO2=0.0-0.2
Biological distribution of 99mTc-DMSA in Rat (n=3), Expressed in % injected
dose/Critical organ:
Liver and spleen
< 5.0 %
Stomach, Intestine
< 1.0 %
Ratio of kidney to liver and spleen
> 6.0
Sterility Test
Test for sterility on kits for 99mTc-Radiopharmaceuticals are carried out as
described in U.S. pharmacopeia.
Pyrogen Test
LAL test and rabbit test on kit for 99mTc-Radiopharmaceuticals are carried out
as described in U.S. pharmacopeia.

Sn++ Tck-pars-600

KIT FOR THE PREPARATION OF (Sn) 99mTc Red Blood Cell (RBC) In-vitro labelling, for INJECTION
Indication: GI bleeding, blood pool imaging
Each package contains 3 lyophilized kits and 2 vials solution.
1- Each of 3 lyophilized vials contains, in vacuum sterile and pyrogen free
mixture of:
Sodium citrate dehydrate
3.70 mg
Stannous chloride dihydrate
0.105 mg
Anhydrous dextrose

5.5 mg
2- Each of two vials for three times labelling contains:
a.Brown color vial; sodium hypochlorite
2.3 ml
b.Colorless vial; ACD solution
3.6 ml
Storage
Store the kit and solutions

2-8 C
Store the reconstituted kit
15-25 C
Preparation (Labelling procedure In-vitro)
Take 0.1 ml of ACD solution by the syringe (19-21G needle).
Collect patients blood in 1-3 ml, mix gently.
Inject the patients blood to lyophilized vial (reaction vial), mix slowly
and wait for 5 min.
Inject 0.6 ml of sod. Hypochlorite (2-a) to the reaction vial, then mix gently.
Inject 1.0 ml of ACD solution (2-b) to the reaction vial and then mix gently.
Inject 10-100 mCi of sodium pertechnetate (99mTcO-4) in 1-3 ml to the

reaction vial, then mix gently and wait for 20 minutes.

Inject the labelled 99mTc-RBC to the patient within 30min after labelling
time (by syringe19-21G needle).
Quality control of 99mTc-RBC
Take 0.2 ml of labelled 99mTc-RBC and transfer to the centrifuge tube.
Add 2 ml of normal saline to the centrifuge tube and shake well.
Centrifuge in 500 RCF at 10 min.
Separate accurately the 99mTc-RBC from plasma.
%99mTc-RBC=(Activity of 99mTc-RBC /Total activity of RBC and
plasma) x100
Labelling efficiency
>95 %
Sterility Test
Test for sterility on kits for 99mTc-Radiopharmaceuticals are carried out as
described in U.S. pharmacopeia.
Pyrogen Test
LAL test and rabbit test on kit for 99mTc-Radiopharmaceuticals are carried
out as described in U.S. pharmacopeia.

PYP Tck-pars-900

KIT FOR THE PREPARATION OF PYROPHOSPHATE (Sn) Tc-99m INJECTIO1V

Indication: Myocardial imaging agent
Labeled preparation is to be used within 6 hours. Within this period
Each vial contains, in vacuum, a lyophilized, sterile and pyrogen free mixture of:
the total RCP of
Sodium pyrophosphate decahydrate
14.0 mg
99mTc-PYP should be more than 95.0 %.
Stannous chloride dehydrate
1.0 mg
Quality control of 99mTc-PYP
After adding a sterile and pyrogen free solution of pertechnetate 99mTc, one
P.Chromatography No.1 (Whatman) /Methanol- Acetone (1: 1)
obtains an injectable solution of 99mTc - (Sn)-PYP with the following charac Rf 99m TcO-4 = 0.75
teristics:
P.Chromatograghy No.1 (Whatman) /phosphoric Acid 15%
Volume
2-6 ml
Rf 99m TcO2 = 0.0-0.2
Max activity
80 mCi
Biological Distribution of 99mTc-PYP in Rat (n=3), Expressed in % dose/
Radiochemical purity
> 95.0 %
Critical organ:
PH
5-6
Liver, Kidney
< 5.0
Storage
Store the kit
Store the reconstituted kit

2-25C
15-25C

Bone (one femur)

Stomach, Intestine

>1.0
< 1.0

Sterility Test
Preparation
Test for sterility on kits for 99mTc-Radiopharmaceuticals are carried out as de99m
Inject sterile
Tc (up to 80 mCi) aseptically into the vial a volume of scribed in U.S. pharmacopeia.
2-6 ml
Pyrogen Test
Dissolve the lyophilized material by shaking the vial for 10 seconds.
LAL test and rabbit test on kits for 99mTc-Radiopharmaceuticals are carried out
Wait for 15 min.
as described in U.S. pharmacopeia.
Examine the radiochemical purity (RCP).

BRIDA Tck-pars-1000

KIT FOR THE PREPARATION OF TRIMETHYL- BROMO- IDA (Sn) 99mTc INJECTION
Indication: Visualization of the hepatobiliary system, examination of the
hepatobiliary function.
Each vial contains, in vacuum, a lyophilized, sterile and pyrogen free mixture of:
N-(2,4,6- trimethyl-3-bromoacetanilido iminodiacetic acid(Mebrofenin)25.0 mg
Stannous chloride dehydrate
0.20 mg
After adding a sterile and pyrogen free solution of pertechnetate 99mTc, one
obtains an inject able solution of 99mTc -(Sn)-Br-IDA with the following characteristics:
Volume
up to 5.0 ml
Max. Activity
50.0 mCi
Radiochemical purity
> 95.0 %
PH
5-6
Storage
Store the kit
2-8 C
Store the reconstituted injection
15-25 C
Preparation
Inject sterile 99mTc (up to 50 mCi) aseptically into the vial in a volume of 2-5 ml
Dissolve the lyophilized material by shaking the vial for 10 seconds.
Wait for 15 minutes.
Examine the radiochemical purity (RCP).

Labelled preparation is to be used within 4 hours. Within this period the

total RCP of 99mTc-Br-IDA should be more than 95.0 %.
Quality control of 99mTc-BrIDA
P. Chromatography No.1 (What man) /D.W
Rf 99mTcO2 = 0.0-0.1
ITLC-SG/N. saline
Rf 99mTcO-4 = 0.9-0.1
Biological Distribution of 99mTc-BrlDA in Rat (n=3), expressed in %dose/
Critical organ:
Intestine
>80.0%
Liver (per gram)
< 1.0
Kidney (per gram)
< 2.5 %
Stomach
< 1.0
Bladder + urine
< 15.0
Sterility Test
Test for sterility on kits for 99mTc- Radiopharmaceuticals are carried out as
described in U.S. pharmacopeia.
Pyrogen Test
LAL test and rabbit test on kits for 99mTc-Radiopharmaceuticals are carried
out as described in U.S. pharmacopeia.

DMSA (V) Tck-pars-1100

KIT FOR THE PREPARATION OF DIMERCAPTOSUCCINIC ACID (Sn) 99mTc INJECTION

Indication: exploration of the renal morphology and the functional state of
each kidney by measurement of the renal uptake
Each vial contains, in vacuum, a lyophilized, sterile and pyrogen free mixture of:
DMSA (Dimercaptosuccinic Acid)
1.20 mg
Stannous chloride dihydrate

0.35 mg
Ascorbic acid

0.30 mg
Myo-inositol
50.0 mg
After adding a sterile and pyrogen free solution of pertechnetate 99mTc, one obtains an injectable solution of 99mTc-(Sn)-DMSA with the following characteristics:
Volume


up to 6.0 ml
Activity
40.0 mCi
Radiochemical purity
> 90.0 %
PH
2.3-3.5
Storage
Store the kit
Store the reconstituted kit

2-8 C, protect from light

15-25 C

Preparation
Inject sterile 99mTc (up to 40 mCi) aseptically into the vial in a volume of 2.5 ml
Dissolve the lyophilized material by shaking the vial for 10 seconds
Wait for 15 min at the room temperature

Examine the radiochemical purity (RCP)

Labelled preparation is to be used within 4 hours after labelling. Within
this period the total RCP of 99mTc-DMSA should be more than 90.0%.
Quality control of 99mTc-DMSA
P.Chromatography No.1 (Whatman)/MEK/Glycine 5%
Rf 99mTcO-4=0.8-1.0
Rf 99mTcO2=0.0-0.2
Biological distribution of 99mTc-DMSA in Rat (n=3), Expressed in % injected
dose/Critical organ:
Liver and spleen
< 5.0 %
Stomach, Intestine
< 1.0 %
Ratio of kidney to liver and spleen
> 6.0
Sterility Test
Test for sterility on kits for 99mTc-Radiopharmaceuticals are carried out as
described in U.S. pharmacopeia.
Pyrogen Test
LAL test and rabbit test on kit for 99mTc-Radiopharmaceuticals are carried
out as described in U.S. pharmacopeia.

MIBI Tck-pars-1200

KIT FOR THE PREPARATION OF MIBI (Sn) 99mTc INJECTION

Indication: Myocardial perfusion scintigraphy
Each vial contains, in vacuum, a lyophilized, sterile and pyrogen free mixture of:
Cu (MIBI)4BF4
0.50 mg
Stannous chloride dihydrate
0.30 mg
Glycine
32.0 mg
Sodium pyrophosphate
5.20 mg
Cysteine
2.0 mg
After adding a sterile and pyrogen free solution of pertechnetate 99mTc, shake
the vial for 10 seconds. Then, place the vial into a boiling water bath for 10
minutes. Wait for 15 minutes until it cools to room temperature. 99mTc -(Sn)MIBI has the following characteristics:
Volume
1 - 3 ml
Max. Activity
up to 150 mCi
Radiochemical purity
> 95.0 %
PH
5.5 -6.5
Stability of 99mTc -MIBI
6h
Storage
Store the kit
2 - 8 C
Store the reconstituted kit
15 - 25 C
Preparation
Add aseptically sterile and non-pyrogenic 99mTc (10 - 150 mCi) in app. 1 to 3 ml.
Shake the contents of the vial for a few seconds.

Place upright the vial in a boiling water bath for 10 minutes.

Wait for 15 minutes at the room temperature.
The reconstituted solution is stable for 6 hrs.
Quality control of 99mTc-MIBI
What man paper chromatography No.1 /Methanol
Rf 99mTcO2 = 0.0 - 0.3
ITLC-SG/Normal saline
Rf 99mTcO-4 = 0.9 - 1.0
Biological distribution of 99mTc-MIBI in mice (n = 3), expressed in % injected
dose per critical organ:
Liver
> 20.0%
Heart
> 1.3%
Kidney
> 7.0%
Intestine
> 30.0%
Stomach
< 1.0%
Sterility test
Test for sterility on kits for 99mTc-radiopharmaceuticals are carried out as
described in U.S. pharmacopeia.
Pyrogen test
LAL test and rabbit test on kits for 99mTc-radiopharmaceuticals are carried
out as described in U.S. pharmacopeia.

Phytate Tck-pars-1400

KIT FOR THE PREPARATION OF PHYTATE (Sn)Tc-99m INJECTION

INDICATION: Liver/ spleen scintigraphy
Each vial contains, in vacuum, a lyophilized, sterile and pyrogen free mixture
of:
Phytic acid
10.0mg
Stannous chloride dehydrate
1.0mg
After adding a sterile and pyrogen free solution of pertechnetate 99mTc, one
obtains an injectable solution of 99mTc-(Sn)-phytate with the following characteristics:
Volume
3-6ml
Max activity
100mci
Radiochemical purity
>95.0%
PH
5.5-6.5
Storage
Store the kit
2-8c
Store the reconstituted injection
15-25c
Preparation
Inject sterile 99mTc (up to 100mCi) aseptically into the vial in a volume
of 3-6 ml.
Dissolve the lyophilized material by shaking the vial for 10 seconds.
Wait for 15 minutes.
Examine the radiochemical purity(RCP)

Labelled preparation is to be use within 6 hrs. Within this period the total
RCP of 99mTc-phytate should be more than 95.0%.
Quality control of 99mTc-phytate
P.Chromatography No.1(Whatman) / Methanol-Acetone(1:1)
Rf 99mTc0-4=0.75-1.0
Biological Distribution of 99mTc-phytate in mice (n=3), Expressed in %dose/
Critical organ:
Lung
<5.0
Liver and spleen
>80.0
Stomach, Intestine
<1.0
Sterility Test
Test for sterility on kits for 99mTc-Radiopharmaceuticals are carried out as
described in U.S. pharmacopeia.
Pyrogen Test
LAL test and rabbit test on kits for 99mTc-Radiopharmaceuticals are carried
out as described in U.S. pharmacopeia.

EC Tck-pars-1600

KIT FOR THE PREPARATION OF 99mTc (Sn)-EC INJECTION

Indication: Renal tubular function imaging
Each vial contains, in vacuum, a lyophilized, sterile and pyrogen free mixture of:
Ethylene dicysteine
Stannous chloride dihydrate

1.0 mg
0.125 mg

After adding a sterile and pyrogen free solution of pertechnetate 99mTc, shake
the vial for 10 seconds.
Add 2 ml of phosphate buffer solution, shake for 10 seconds. Wait for 15 min.
99mTc (Sn)-EC has the following characteristics:
Volume

up to 5 ml
Activity
10-100 mCi
Radiochemical purity
> 95.0 %
PH
7.5-8.5
Stability of 99mTc-EC

4 hrs
Storage
Store the kit
2-8 C
Store the reconstituted kit
15-25 C
Preparation
Add aseptically sterile, non-pyrogenic 99mTc (10-150mCi) in app.1 to 3 ml.
Shake the contents of the vial for a few seconds.

10

Add 2.0 ml phosphate buffer.

Shake again for a few seconds.
Wait for 15 min at the room temperature
The reconstituted solution is stable for 4 hrs.
Quality control of 99mTc-EC
P.Chromatography No.3 (Whatman)/Acetic Acid 0.5M
Rf 99mTcO2=0.0
ITLC-SG/Acetone
Rf 99mTcO-4=0.9-1.0
Biological distribution of 99mTc-EC in Rat (n=3), Expressed in % dose/Critical
organ:
Stomach
< 5.0
Kidney
> 35.0
Sterility Test
Test for sterility on kits for 99mTc-Radiopharmaceuticals are carried out as
described in U.S. pharmacopeia.
Pyrogen Test
LAL test and rabbit test on kit for 99mTc-Radiopharmaceuticals are carried
out as described in U.S. pharmacopeia.

ECD Tck-pars-1700

KIT FOR THE PREPARATION OF 99mTc (Sn)-ECD INJECTION

Indication: Brain perfusion imaging
Each vial contains, in vacuum, a lyophilized, sterile and pyrogen free mixture of:
Ethyl cysteinate Dimer
1.0 mg
EDTA
360.0 g
Mannitol
24.0 mg
Stannous chloride dihydrate
100.0 g
After adding a sterile and pyrogen free solution of pertechnetate 99mTc, shake
the vial for 10 seconds.
Add 2 ml of phosphate buffer solution, shake for 10 seconds. Wait for 45 min.
99mTc (Sn)-ECD has the following characteristics:
Volume

up to 5 ml
Activity
10-100 mCi
Radiochemical purity
> 90.0 %
PH
7.5-8.0
Stability of 99mTc-ECD
4 hrs
Storage
Store the kit

2-8 C
Store the reconstituted kit
15-25 C
Preparation
Add aseptically sterile, non-pyrogenic 99mTc (10-100mCi) in app.1 to 2 ml.
Shake the contents of the vial for a few seconds.

11

Add 2.0 ml phosphate buffer.

Shake again for a few seconds.
Wait for 45 min at the room temperature
The reconstituted solution is stable for 4 hrs.
Quality control of 99mTc-ECD
Revers Phase Chromatography
MKC-18/Acetone-Am.Acetate(6:4)
Rf 99mTcO2=0.0
Rf 99mTcO-4=1.0
Biological distribution of 99mTc-ECD in mice (n=3), Expressed in % dose/
Critical organ (1 min after injection):
Brain
0.9-1.3
Stomach
< 1.5
Liver
>10.0
Kidney , Intestine
<10.0
Sterility Test
Test for sterility on kits for 99mTc-Radiopharmaceuticals are carried out as
described in U.S. pharmacopeia.
Pyrogen Test
LAL test and rabbit test on kit for 99mTc-Radiopharmaceuticals are carried out
as described in U.S. pharmacopeia.

MAA Tck-pars-1800

KIT FOR THE PREPARATION OF AN INJECTABLE SUSPENSION OF HUMAN SERUM ALBUMIN MACROAGGRIGATES (Sn) 99mTc
Indication: lung scintigraphy.
Each vial contains, in vacuum, a lyophilized, sterile and pyrogen free mixture of:
Human serum albumin macroaggrigates
3.0 mg
Stannous chloride dehydrate
0.03 mg
Tween-80
0.057 mg
After adding a sterile and pyrogen free solution of pertechnetate Tc-99m, one
obtains an injectable solution of 99mTc - (Sn) - macroaggrigates with the following characteristics:
Volume
up to 5.0 ml
Activity
5 - 30.0 mCi
Radiochemical purity
> 95.0 %
PH
5.5 -6.5
Size of particles after labelling
10 - 90 m
Number of particles per vial
700000 - 1000000
Number of particles for injection (adult)
200000 - 300000
Storage
Store the kit
2 - 8 C
Store the reconstituted kit
15-25C
Preparation
Injection sterile 99mTc (5 - 40 mCi) aseptically into the vial in a volume of 2 - 5 ml.
Dissolve the lyophilized material by shaking the vial for 10 seconds and

12

wait for 15 minutes.

Examine the radiochemical purity (RCP).
Labelled preparation is to be used within 6 hours. Within this period the
total RCP of 99mTc-MAA should be more than 95.0%.
Shake before using.
Quality control of 99mTc-MAA
What man paper chromatography No.1 /Methanol-Acetone (1: 1)
Rf 99mTcO-4 = 0.75
Rf 99mTcO2 + 99mTc-Complex = 0.0 - 0.2
Biological distribution of 99mTc-MAA in mice (n = 3), expressed in % injected
dose per critical organ:
Liver and spleen
< 5.0%
Lung
> 80.0%
Stomach, Intestine
< 1.0
Sterility test
Test for sterility on kits for 99mTc-radiopharmaceuticals are carried out as
described in U.S. pharmacopeia.
Pyrogen test
LAL test and rabbit test on kits for 99mTc-radiopharmaceuticals are carried
out as described in U.S. pharmacopeia.

Sulfurcolloid Tck-pars-1900

KIT FOR THE PREPARATION OF 99mTc Sulfurcolloid INJECTION

Indication: GI system, Liver / Spleen scintigraphy.
Each package contains 3 kits as solution (reaction vial) and 2 solution vials,
sterile and pyrogen free.
1- Each of 3 reaction vials contains:
Sodium thiosulfate anhydrous
2.72 mg
2- Each of two solution vials contains:
a.Hydrochloric acid solution (for 3 labelling)
1.2 ml
b.Phosphate buffer solution (for 3 labelling)
4.0 ml
Storage
Store the kit and solutions

2-8 C
Store the reconstituted kit
15-25 C
Preparation
Add 0.1 ml of hydrochloric acid solution (2-a) to the reaction vial.
Add 10-100 mCi of freshly pertechnetate (99mTcO-4) in 1-2 ml to the
reaction vial.
Heat 30 min in boiling water bath.
Cool, add 1.3 ml of phosphate buffer solution (2-b) to reaction vial.
The reconstituted solution is stable for 4 hrs.
Quality control of 99mTc-Sulfurcolloid
P.Chromatography No.3 (Whatman)/Normal saline

13

Rf 99mTcO2+99mTc- Sulfurcolloid
Rf 99mTcO-4
Radiochemical purity

0.0-0.20
0.20-1.0
> 95.0 %

Biological distribution of 99mTc- Sulfocolloid in mice (n=3) after 30 min,

Expressed in % dose/Critical organ:
Liver+ spleen
>75.0
lung
<5.0
Sterility Test
Test for sterility on kits for 99mTc-Radiopharmaceuticals are carried out as
described in U.S. pharmacopeia.
Pyrogen Test
LAL test and rabbit test on kit for 99mTc-Radiopharmaceuticals are carried
out as described in U.S. pharmacopeia.

Antimony TS

Tck-pars-2100

KIT FOR THE PREPARATION OF 99mTc Antimony trisulfide INJECTION

Indication: Lymphoscintigraphy.
Each package contains 3 red solution vials (reaction vial) and 2 colorless solution vials, as sterile and pyrogen free.
1- Each of 3 reaction vials contains:
Antimony trisulfide

1.50 mg
2- Each of two colorless solution vials contains:
a.Hydrochloric acid solution (for 3 labelling)
2.0 ml
b.Phosphate buffer solution (for 3 labelling)
4.0 ml
Storage
Store the kit and solutions

Store the reconstituted kit

2-8 C
15-25 C

Preparation
Add 0.5 ml of hydrochloric acid solution (2-a) to the reaction vial (red
solution).
Add 10-100 mCi of freshly pertechnetate (99mTcO-4) in 1-3 ml to the reaction vial.
Heat 30 min in boiling water bath.
Cool, add 1.0 ml of phosphate buffer solution (2-b) to reaction vial.
The reconstituted solution is stable for 4 hrs.

14

Quality control of 99mTc-Antimony trisulfide

P.Chromatography No.3 (Whatman)/Normal saline
Rf 99mTcO2+99mTc-Antimony trisulfide
Rf 99mTcO-4
Radiochemical purity

0.0-0.20
0.20-1.0
> 95.0%

Biological distribution of 99mTc- Antimony trisulfide in mice (n=3) after 20 min,

Expressed in % dose/Critical organ:
Liver+ spleen
> 75.0
Lung
< 5.0
Sterility Test
Test for sterility on kits for 99mTc-Radiopharmaceuticals are carried out as
described in U.S. pharmacopeia.
Pyrogen Test
LAL test and rabbit test on kit for 99mTc-Radiopharmaceuticals are carried
out as described in U.S. pharmacopeia.

TYROSINE OCTREOTIDE Tck-pars-2300

KIT FOR THE PREPARATION OF 99mTc-TYROSINE-OCTREOTIDE INJECTION

Indication: Recommended for localization, staging and therapy follow-up of tumors of
neuroendocrine origin with positive somatostatin receptors.
Characteristics: Each vial contains, in vacuum, a lyophilized, sterile and pyrogen free
mixture of:
HYNIC-Tyrosine-Octreotide
20 g
Stannous chloride dihydrate
40 g
Tricine
15 mg
EDDA
5 mg
After adding a sterile and pyrogen free solution of 99mTcO4 in saline and incubation
of the vial for 10 min at 95 C, one obtains an injectable solution 99mTc-Tyrosine-Octreotide
with the following characteristics:
Volume
1 ml
Max. Activity
up to 1,480 MBq
Radiochemical purity
> 95.0 %
PH


7
Storage:
Store the kit - 20 C, keep away from light and humidity
Store the reconstituted kit
15 - 25 C
Preparation:
Add 0.5 ml 0.9% saline in an evacuated vial, and allow the mixture to preincubate
for 5 min.
Add aseptically sterile and non-pyrogenic solution of 99mTcO4- (370-1,480 MBq)
in 0.5 mL saline.
Shake the contents of the vial slowly for a few seconds.
Incubate the vial for 10 minutes at 95 C.
Wait 10 minutes for cooling to room temperature.

15

The reconstituted solution is stable for 6 hrs.

Quality control:
ITLC on silica gel 60 (Merck) using different mobile phases: 0.1 M sodium citrate (pH 5)
to determine the non-peptide bound 99mTc coligand and 99mTcO4- (Rf = 1), the mixture of
methanol/1 M ammonium acetate in a volume ratio of 1:1 for 99mTc colloid (Rf = 0). The radioactivity was quantified by cutting the strip (1.5 10 cm2) into 1 cm pieces and counting in
a well type gamma counter. Percent of complex is equal to: 100 - (% non-peptide bound 99mTc
coligand and 99mTcO4- + % 99mTc colloid) which should be over %90.
HPLC with C-18 reverse phase column (250/4.6) and 0.1% trifluoroacetic acid/water (Solvent
A) and acetonitrile (Solvent B) as a mobile phase in the following gradient: 0 min 95% A (5%
B), 5 min 95% A (5% B), 20 min 0% A (100% B), 25 min 0% A (100% B), 30 min 95% A (5%
B), flow = 1 mL/min, Rt of complex ~ 15 min. Percent of complex should be over %90.
Sterility test:
Test for sterility on kits for
U.S. pharmacopeia.

99mTc-radiopharmaceuticals

Pyrogen test:
LAL test and rabbit test on kits for
scribed in U.S. pharmacopeia.

are carried out as described in

99mTc-radiopharmaceuticals

are carried out as de-

Imaging protocols:
For scintigraphy, a bolus injection of 99mTc-Tyrosine-Octreotide, corresponding to activity in the range 555740 MBq added to 20 g of peptide, should be given. Whole-body
anterior and posterior images followed by SPECT views of the region of interest should
also be obtained at 90 min post injection. A high activity adsorption compared to background is considered as a positive result.

TYROSINE OCTREOTATE Tck-pars-2400

KIT FOR THE PREPARATION OF 99mTc-TYROSINE-OCTREOTATE INJECTION

Indication: Recommended for localization, staging and therapy follow-up of tumors of
neuroendocrine origin especially for somatostatin receptor 2 (sstr2) positive tumors
in abdomen due to low background activity and rapid clearance in comparisons with
Octreotide.
Characteristics:
Each vial contains, in vacuum, a lyophilized, sterile and pyrogen free mixture of:
HYNIC-Tyrosine-Octreotate
20 g
Stannous chloride dihydrate
40 g
Tricine
15 mg
EDDA
5 mg
After adding a sterile and pyrogen free solution of 99mTcO4 in saline and incubation
of the vial for 10 min at 95 C, one obtains an injectable solution 99mTc-TyrosineOctreotate with the following Characteristics:
Volume
1 ml
Max. Activity
up to 1,480 MBq
Radiochemical purity
> 95.0 %
PH
7
Storage:
Store the kit
- 20 C, keep awa from light and humidity
Store the reconstituted kit
15 - 25 C
Preparation:
Add 0.5 ml 0.9% saline in an evacuated vial, and allow the mixture to preincubate for 5 min.
Add aseptically sterile and non-pyrogenic solution of 99mTcO4 (370-1,480 MBq)
in 0.5 mL saline.
Shake the contents of the vial slowly for a few seconds.
Incubate the vial for 10 minutes at 95 C.

16

Wait 10 minutes for cooling to room temperature.

The reconstituted solution is stable for 6 hrs.
Quality control:
ITLC on silica gel 60 (Merck) using different mobile phases: 0.1 M sodium citrate (pH 5) to determine the non-peptide bound 99mTc coligand and 99mTcO4- (Rf = 1), the mixture of methanol/1 M ammonium acetate in a volume ratio of 1:1 for 99mTc colloid (Rf = 0). The radioactivity
was quantified by cutting the strip (1.5 10 cm2) into 1 cm pieces and counting in a well type
gamma counter. Percent of complex is equal to: 100 - (% non-peptide bound 99mTc coligand and
99mTcO4- + % 99mTc colloid) which should be over %90.
HPLC with C-18 reverse phase column (250/4.6) and 0.1% trifluoroacetic acid/water (Solvent A)
and acetonitrile (Solvent B) as a mobile phase in the following gradient: 0 min 95% A (5% B), 5 min
95% A (5% B), 20 min 0% A (100% B), 25 min 0% A (100% B), 30 min 95% A (5% B), flow = 1 mL/
min, Rt of complex ~ 15 min. Percent of complex should be over %90.
Sterility test:
Test for sterility on kits for 99mTc-radiopharmaceuticals are carried out as described in U.S.
pharmacopeia.
Pyrogen test:
LAL test and rabbit test on kits for 99mTc-radiopharmaceuticals are carried out as described in
U.S. pharmacopeia.
Imaging protocols:
For scintigraphy, a bolus injection of 99mTc-Tyrosine-Octreotate,
corresponding to activity in the range 555740 MBq added to 20 g of peptide, should be
given. Whole-body anterior and posterior images followed by SPECT views of the region of
interest should also be obtained at 60 min post injection. A high activity adsorption
compared to background is considered as a positive result.

HYNIC UBI Tck-pars-2500

KIT FOR THE PREPARATION OF 99mTc-UBIQUICIDINE INJECTION

Indication: Recommended for infection detection especially discrimination between
infection and sterile inflammation.
Characteristics:
Each vial contains, in vacuum, a lyophilized, sterile and pyrogen free mixture of:
HYNIC-Ubiquicidine (29-41)
40 g
Stannous chloride dihydrate
40 g
Tricine
20 mg
After adding a sterile and pyrogen free solution of 99mTcO4 in saline and incubation
of the vial for 10 min at 95 C, one obtains an injectable solution 99mTc-Ubiquicidine
with the following Characteristics:
Volume
1 ml
Max. Activity
up to 1,480 MBq
Radiochemical purity
> 95.0 %
PH
5
Storage:
Store the kit
- 20 C, keep away from light and humidity
Store the reconstituted kit
15 - 25 C
Preparation:
Add 0.5 ml 0.9% saline in an evacuated vial, and allow the mixture to preincubate
for 5 min.
Add aseptically sterile and non-pyrogenic solution of 99mTcO4 (370-1,480 MBq)
in 0.5 mL saline.
Shake the contents of the vial slowly for a few seconds.
Incubate the vial for 10 minutes at 95 C.
Wait 10 minutes for cooling to room temperature.
The reconstituted solution is stable for 6 hrs.

17

Quality control:
ITLC on silica gel 60 (Merck) using different mobile phases: 0.1 M sodium citrate (pH 5) to
determine the non-peptide bound 99mTc coligand and 99mTcO4- (Rf = 1), the mixture of
methanol/1 M ammonium acetate in a volume ratio of 1:1 for 99mTc colloid (Rf = 0). The
radioactivity was quantified by cutting the strip (1.5 10 cm2) into 1 cm pieces and counting
in a well type gamma counter. Percent of complex is equal to: 100 - (% non-peptide bound
99mTc coligand and 99mTcO4- + % 99mTc colloid) which should be over %90.
HPLC with C-18 reverse phase column (250/4.6) and 0.1% trifluoroacetic acid/water (Solvent A) and acetonitrile (Solvent B) as a mobile phase in the following gradient: 0 min 95%
A (5% B), 5 min 95% A (5% B), 20 min 0% A (100% B), 25 min 0% A (100% B), 30 min 95%
A (5% B), flow = 1 mL/min, Rt of complex ~ 14 min. Percent of complex should be over %90.
Sterility test:
Test for sterility on kits for 99mTc-radiopharmaceuticals are carried out as described in U.S.
pharmacopeia.
Pyrogen test:
LAL test and rabbit test on kits for 99mTc-radiopharmaceuticals are carried out as described
in U.S. pharmacopeia.
Imaging protocols:
For scintigraphy, a bolus injection of 99mTc-Ubiquicidine, corresponding to activity in the range
555740 MBq added to 40 g of peptide, should be given. Immediately after injection, dynamic
imaging should be acquired for the suspected infection area and the contralateral healthy
side as a non-target area. The dynamic study should be performed immediately after injection
with 60 s for each frame up to 30 min. Whole-body anterior and posterior images followed by
SPECT views of the region of interest should also be obtained at 30 min post injection. A high
and stable activity adsorption compared to background is considered as a positive result.

HYNIC BOMBESIN Tck-pars-2600

KIT FOR THE PREPARATION OF 99mTc-BOMBESIN INJECTION

Indication: Recommended for localization, staging and therapy follow-up of breast
and prostate tumors with positive gastrin releasing peptide receptor (GRPr).
Characteristics:
Each vial contains, in vacuum, a lyophilized, sterile and pyrogen free mixture of:
HYNIC-GABA-Bombesin (7-14)
20 g
Stannous chloride dihydrate
40 g
Tricine

15 mg
EDDA
5 mg
After adding a sterile and pyrogen free solution of 99mTcO4 in saline and incubation
of the vial for 10 min at 95 C, one obtains an injectable solution 99mTc-Bombesin with
the following Characteristics:
Volume
1 ml
Max. Activity
up to 1,480 MBq
Radiochemical purity
> 95.0 %
PH
7
Storage:
Store the kit
- 20 C, keep away from light and humidity
Store the reconstituted kit
15 - 25 C
Preparation:
Add 0.5 ml 0.9% saline in an evacuated vial, and allow the mixture to preincubate for
5 min.
Add aseptically sterile and non-pyrogenic solution of 99mTcO4 (370-1,480 MBq)
in 0.5 mL saline.
Shake the contents of the vial slowly for a few seconds.
Incubate the vial for 10 minutes at 95 C.
Wait 10 minutes for cooling to room temperature.

18

The reconstituted solution is stable for 6 hrs.

Quality control:
ITLC on silica gel 60 (Merck) using different mobile phases: 0.1 M sodium citrate (pH 5) to determine the non-peptide bound 99mTc coligand and 99mTcO4- (Rf = 1), the mixture of methanol/1
M ammonium acetate in a volume ratio of 1:1 for 99mTc colloid (Rf = 0). The radioactivity was
quantified by cutting the strip (1.5 10 cm2) into 1 cm pieces and counting in a well type gamma
counter. Percent of complex is equal to: 100 - (% non-peptide bound 99mTc coligand and 99mTcO4- +
% 99mTc colloid) which should be over %90.
HPLC with C-18 reverse phase column (250/4.6) and 0.1% trifluoroacetic acid/water (Solvent
A) and acetonitrile (Solvent B) as a mobile phase in the following gradient: 0 min 95% A (5%
B), 5 min 95% A (5% B), 20 min 0% A (100% B), 25 min 0% A (100% B), 30 min 95% A (5% B),
flow = 1 mL/min, Rt of complex ~ 16 min. Percent of complex should be over %90.
Sterility test:
Test for sterility on kits for 99mTc-radiopharmaceuticals are carried out as described in
U.S. pharmacopeia.
Pyrogen test:
LAL test and rabbit test on kits for 99mTc-radiopharmaceuticals are carried out as described in U.S. pharmacopeia.
Imaging protocols:
For scintigraphy, a bolus injection of 99mTc-Bombesin, corresponding to activity in the range
555740 MBq added to 20 g of peptide, should be given. Immediately after injection, dynamic imaging should be acquired for the suspected tumor area and the contralateral healthy
side as a non-target area. The dynamic study should be performed immediately after injection
with 60 s for each frame up to 30 min. Whole-body anterior and posterior images followed
by SPECT views of the region of interest should also be obtained at 60 min post injection. A
high and stable activity adsorption compared to background is considered as a positive result.

CIPROFLOXACIN

Tck-pars-2700

KIT FOR THE PREPARATION OF 99mTc-CIPROFLOXACIN INJECTION

Indication:Recommended for infection detection specially in legs and hands.
Characteristics: Each vial contains, in vacuum, a lyophilized, sterile and pyrogen
free mixture of:
Ciprofloxacin
2 mg
Stannous chloride dihydrate
100 g

After adding a sterile and pyrogen free solution of 99mTcO4 in saline and incubation
of the vial for 20 min at room temperature, one obtains an injectable solution 99mTcCiprofloxacin with the following Characteristics:
Volume
1 ml
Max. Activity
up to 740 MBq
Radiochemical purity
> 90.0 %
PH
4
Storage:
Store the kit - 8 C, keep away from light and humidity
Store the reconstituted kit
Preparation:
Add aseptically sterile and non-pyrogenic solution of
99mTcO4 (370-740 MBq) in 1 mL saline.
Shake the contents of the vial slowly for a few seconds.
Incubate the vial for 20 minutes at room temperature.
The reconstituted solution is stable for 6 hrs.

19

15 - 25 C

Quality control:
ITLC-SG using different mobile phases: Acetone for free 99mTcO4- (Rf = 1)
and ethanol: water: ammonium hydroxide (2: 5: 1 v/v) for 99mTc colloid (Rf =
0). The radioactivity was quantified by cutting the strip (1.5 10 cm2) into 1 cm
pieces and counting in a well type gamma counter. Percent of complex is equal
to: 100 - (% 99mTcO4- + % 99mTc colloid) which should be over %90.
Sterility test:
Test for sterility on kits for 99mTc-radiopharmaceuticals are carried out as
described in U.S. pharmacopeia.
Pyrogen test:
LAL test and rabbit test on kits for 99mTc-radiopharmaceuticals are carried out
as described in U.S. pharmacopeia.
Imaging protocols:
For scintigraphy, a bolus injection of 99mTc-Ciprofloxacin, corresponding to activity in the range 555740 MBq added to 2 mg of antibiotic, should be given. Immediately after injection, dynamic imaging should be acquired for the suspected infection area and the contralateral healthy side as a non-target area. The dynamic
study should be performed immediately after injection with 60 s for each frame up
to 30 min. Whole-body anterior and posterior images followed by SPECT views
of the region of interest should also be obtained at 60 min post injection. A high
and stable activity adsorption compared to background is considered as a positive
result.

TRODOT-1 Tck-pars-2800

KIT FOR THE PREPARATION OF 99mTc-TRODAT-1 INJECTION

Indication: Recommended for Imaging of dopamine transporters (DAT) located in
the dopaminergic presynaptic neuron terminals in the striatum which is useful in (1)
differential diagnosis of Parkinsons disease (PD) from non- Parkinsons disease
(with a focus on Parkinsonism), (2) early diagnosis of Parkinsons disease, (3) the
diagnosis of other movement disorders such as Machado Josephs Disease, (4) the
reduction of DAT due to other genetic mutations, (5) blocking of DAT due to drugs
such as methylphenidate (or heavy metal exposure), (6) monitoring the effectiveness of deep brain stimulation and (7) coupling imaging procedures to patient.
Characteristics:
Each vial contains, in vacuum, a lyophilized, sterile and pyrogen free mixture of:
TRODAT-1
Stannous chloride dihydrate
Mannitol
Tricine
After adding a sterile and pyrogen free solution of 99mTcO4 in saline and incubation of the vial for 30 min at 95 C, one obtains an injectable solution 99mTc-TRODAT-1 with the following characteristics:
Volume
1 ml
Max. Activity
up to 1,480 MBq
Radiochemical purity
> 95.0 %
PH
6-7
Storage:
Store the kit
- 20 C, keep away from light and humidity
l Store the reconstituted kit
15 - 25 C

20

Preparation:
l Add 0.5 ml 0.9% saline in an evacuated vial, and allow the mixture to preincubate for 5 min.
l Add aseptically sterile and non-pyrogenic solution of 99mTcO4- (925-1,480 MBq)
in 0.5 mL saline.
l Shake the contents of the vial slowly for a few seconds.
l Incubate the vial for 30 minutes at 95 C.
l Wait 30 minutes for cooling to room temperature.
lThe reconstituted solution is stable for 6 hrs.
Quality control:
l HPLC with C-18 reverse phase column (250/4.6) and 0.1% trifluoroacetic acid/
water (Solvent A) and acetonitrile (Solvent B) as a mobile phase in the following gradient: 0 min 95% A (5% B), 5 min 95% A (5% B), 20 min 0% A (100% B), 25 min 0%
A (100% B), 30 min 95% A (5% B), flow = 1 mL/min, Rt of complex ~ 18 min. Percent
of complex should be over %90.
Sterility test:
Test for sterility on kits for 99mTc-radiopharmaceuticals are carried out as described
in U.S. pharmacopeia.
Pyrogen test:
LAL test and rabbit test on kits for 99mTc-radiopharmaceuticals are carried out as
described in U.S. pharmacopeia.
Imaging protocols:
l For scintigraphy, a bolus injection of 99mTc-TRODAT-1, corresponding to
activity in the range 814-1036 MBq should be given. SPECT views of the region of
interest should be obtained at 240 min post injection.